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NCT02567916 Clinical Trial

A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol

Pain Clinical Trial

Official title:
A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02567916
Other study ID # 2014-08-026-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2015
Est. completion date February 2017

Study information
Verified date April 2020
Source Kyungpook National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy.

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date February 2017
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- age >15 yrs

- ASA (American Society of Anesthesiologists risk class III-IV)I-II

- patients undergoing to gastroscopy

Exclusion Criteria:

- significant systemic disease (American Society of Anesthesiologists risk class III-IV)

- history of allergic reactions to any of the study drugs

- chronic use of opioid analgesics

- psychiatric disorder

- arrythmia

- pregnancy

- age <18 yrs

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fresofol

• Propofol

Locations
Country Name City State
Korea, Republic of Keimyung University Dongsan Medical Center Daegu

Sponsors (1)
Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Ozawa A, Isono M, Ueno T, Kosaka Y, Nakano T, Inamura M, Kanai A, Okamoto H, Hoka S, Nomiyama S. [Comparison of propofol LCT and propofol MCT/LCT regarding the injection pain at different sites and the memory]. Masui. 2005 Nov;54(11):1241-6. Japanese. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol). 2 hours
Secondary Patient Satisfaction With Sedation Including the Recall of Pain. 2 hours and 5-7days after the end of the procedure
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